Photo Credit: iStock.com/ALIOUI Mohammed Elamine

Findings from the OPTIMUM study showed that microultrasonography-guided biopsy was noninferior to MRI-guided fusion biopsy in diagnosing prostate cancer.

Microultrasonography-guided biopsy is noninferior to MRI-guided fusion biopsy in diagnosing prostate cancer, according to findings from the OPTIMUM study published in JAMA.

Furthermore, according to study author Adam Kinnaird, MD, PhD, of the University of Alberta, and colleagues, the technology is less costly and easier to use than MRI, and could enable faster diagnosis, reduce the need for multiple hospital visits, and free up MRI for other uses given limited MRI capacity worldwide.

The OPTIMUM Study

OPTIMUM was an international, prospective, open-label, noninferiority, randomized, phase 3 study of biopsy-naïve men aged 18 years and older with a clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] and/or abnormal digital examination findings). The study was conducted at 20 centers from December 2021 to September 2024.

A total of 677 men were included and randomly assigned to one of three treatment arms: microultrasonography-guided biopsy (n=121), microultrasonography/MRI fusion-guided biopsy (microultrasonography/MRI; n=226, in which microultrasonography biopsies were performed before unblinding the MRI), or MRI/conventional US fusion-guided biopsy (MRI/conventional ultrasonography; n=331). All patients received synchronous systematic biopsy. No significant differences in PSA level, digital rectal examination findings, or other risk-related parameters were found between the three groups.

The primary endpoint was the difference in detection of Gleason Grade Group 2 or higher cancers using microultrasonography-guided biopsy plus systematic biopsy versus MRI/conventional ultrasonography plus systematic biopsy. The secondary endpoint was the difference in detection of Gleason Grade Group 2 or higher cancers found using microultrasonography/MRI plus systematic biopsy versus MRI/conventional ultrasonography plus systematic biopsy. The non-inferiority margin was set at 10%.

Results Back Microultrasonography as MRI Alternative

The researchers detected Gleason Grade 2 or higher cancer in 57 patients (47.1%) in the microultrasonography group, 141 patients (42.6%) in MRI/conventional ultrasonography group, and 106 patients (46.9%) in microultrasonography/MRI group. They reported that microultrasonography-guided biopsy was non-inferior to MRI fusion-guided biopsy for detection of Gleason Grade Group 2 or higher prostate cancer (difference, 3.52%; 95% CI, −3.95% to 10.92%; non-inferiority P<0.001).

Combined biopsy with microultrasonography/MRI was also noninferior vs MRI/conventional ultrasonography software-assisted MRI fusion biopsy using conventional ultrasonography devices (difference, 4.29%; 95% CI, −4.06% to 12.63%; noninferiority P<0.001). Gleason Grade 2 or higher cancer rates using only targeted biopsy were 38% in microultrasonography arm, 34% in MRI/conventional ultrasonography group, and 40% in the microultrasonography/MRI arm; these differences were not significant.

“Microultrasonography represents an alternative to MRI for image-guided prostate biopsy,” concluded the researchers.